Statement Before ACBSA on Blood Supply and Utilization Data – 8/24/01

Statement ofThe American Association of Blood Banks Before the Advisory Committee on Blood Safety and Availability Regarding Blood Supply and Utilization Data

Presented by Theresa L. Wiegmann AABB General Counsel

August 24, 2001

The American Association of Blood Banks is pleased that the Advisory Committee is once again focusing on the important issue of blood supply and utilization data collection. As we have stated previously, we believe that it is absolutely critical that the government help support comprehensive, national blood supply and utilization data collection and analysis. As is commonly quoted in the quality improvement literature: If you can’t measure it, you can’t improve it! We do have the means of measuring several important variables, but we do not have the resources to capture them. Without such data, we cannot assure that the needs of patients requiring transfusions will be met in future months and years.

Before deciding how to move forward with data collection efforts, we urge the committee to establish a mechanism to address the following questions:

For what purpose is the data to be collected?

What are the most pertinent data that should be collected to effectively monitor the blood supply? What data are needed to measure the supply of blood components? What data are needed to monitor the utilization of blood components?

In what increments (eg, annual, monthly, daily) are data needed?

How will the data be analyzed? How will the two separate, and not necessarily matched, strands of supply and utilization data be compared?

How should data results be disseminated? Who needs access to results of data analysis?

What should be done with these analyses? If it is determined that a “shortage” is imminent, what action will be taken and by whom?

The AABB strongly recommends that a panel of experts be convened to discuss the above issues and make decisions regarding the types of data to be collected and the methods for analysis. Neither this committee nor government representatives alone have the necessary expertise to decide what data are needed and how they should be analyzed. The membership of this panel should be designed to recognize as best as possible the diversity of objectives among hospitals, different blood centers and other key players. This expert panel should be formed and meet as soon as possible so that we can move forward with this critical public health issue. The AABB would be pleased to assist in identifying experts and convening the panel.

In determining what data should be collected, the expert panel should define both the objectives and favored methods of data collection. It is critical that uniform definitions be used by facilities providing collection and utilization data. For example, if the panel decided to collect so-called “red, yellow and green” daily inventory data from blood collection centers, we must be sure that all facilities define these terms identically. Similarly, as the AABB has pointed out to the committee previously, individual hospitals define “inventory” and other key terms differently; national data collection efforts should utilize uniform definitions.

In addition, it is critical that we collect quantitative, and not just qualitative data. There are no standard statistical methods to analyze and interpret qualitative data. An expert panel may establish such standard methods for this industry, but they do not exist today. Thus, it is essential, in our opinion, to continue to collect quantitative data on the supply and utilization of blood components. There are standard, well-established methods to analyze and interpret quantitative data. It would be ill-advised to discontinue the collection of quantitative data. Experts must also consider how quantitative supply data already collected by the National Blood Data Resource Center (NBDRC) for the government since January 2000 should best be used to complement/validate “new” data collection methods.

Furthermore, the data collected must be as representative as possible. In the absence of representative or well-characterized institutional samples, how can the results be extrapolated to the national level? The AABB has concerns that the data currently being collected by the Department of Health and Human Services are not adequately representative. Data should be collected from a broad base of hospitals and blood centers.

Although some blood collecting entities have data regarding blood collection and utilization, we believe such data are limited and need to be supplemented in order to obtain a complete picture. All data elements identified by the expert panel as key elements in assessing blood sufficiency need to be collected nationwide. We face a serious problem, and, with the leadership of HHS, we all need to work cooperatively to ensure that we know as much as we can about patient access to blood.

As we have stated before, the AABB believes that both blood collection and utilization data are needed to ensure optimal patient care. We also believe that a private, independent organization, such as the NBDRC, should be responsible for collecting and analyzing these data. The AABB looks forward to continuing to work with the advisory committee and HHS on this critical public health issue.

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The American Association of Blood Banks (AABB) is the professional association for over 8,000 individuals involved in blood banking and transfusion medicine and nearly 2,000 institutions, including blood centers and hospital transfusion services. Our members are responsible for virtually all of the blood collected and more than 80 percent of the blood transfused in the US. For over 50 years, AABB’s highest priority has been to maintain and enhance the safety and availability of the nation’s blood supply.